Clinical Trials List
2025-10-01 - 2029-03-27
Others
Recruiting3
ICD-10G30.0
Alzheimer's disease with early onset
ICD-10G30.1
Alzheimer's disease with late onset
ICD-10G30.8
Other Alzheimer's disease
ICD-10G30.9
Alzheimer's disease, unspecified
ICD-9331.0
Alzheimer's disease
A Multi-Centre, Single Arm, Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of GSK4527226 (AL101) in Participants With Early Alzheimer's Disease
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Trial Applicant
GlaxoSmithKline
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 張庭瑜 Division of Neurology
- Chi-Hung Liu Division of Neurology
- Hsiu-Chuan Wu Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
• Number of patients who experienced adverse events of particular concern (AESIs) during treatment in this OLE trial.
• Number of patients who experienced serious adverse events (SAEs) during treatment in this OLE trial.
• Number of patients who developed amyloid-related imaging abnormalities (ARIAs) and their severity in this OLE trial.
Inclution Criteria
Completion of the Treatment Period in the parent study (NCT06079190).
Participants may have missed doses during the Treatment Period or may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the parent study.
Willing and able to give informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
Availability of an adult person who has frequent and sufficient contact with the participant, is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits, and signs the study partner ICF.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and if of childbearing potential follows contraception requirements outlined in the protocol.
A male participant is eligible to participate if he follows contraception requirements outlined in the protocol.
Exclusion Criteria
QT interval corrected (QTc) assessment at Day 1 that meets the stopping criteria described in the protocol.
Participant is taking or will be starting a prohibited medication described in the protocol.
Evidence of any Amyloid related imaging abnormalities (ARIA) or cerebral macrohemorrhage that meets the permanent discontinuation criteria described in the protocol.
Other newly identified intracranial hemorrhage aneurysm, vascular malformation, infective lesion, space occupying lesion or brain tumor, or other Magnetic resonance imaging (MRI) findings contraindicating participation in the study.
Newly identified infection(s) that may affect the Central nervous system (CNS).
New diagnosis of moderate to severe alcohol and/or substance use disorder.
Change in participant's ability to tolerate MRI procedures, contraindication to MRI, or any other clinical history or examination finding that would pose a potential hazard in combination with MRI.
Newly diagnosed cancer.
Newly identified severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
Newly identified genetic predisposition for clotting disorder or hemorrhagic disease.
Any other clinically significant change in health status (which, in the opinion of the investigator, would make the participant unsuitable for participation in the OLE study.
The Estimated Number of Participants
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Taiwan
8 participants
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Global
226 participants
